• Moving Data for Clinical Trials: Standards, Systems to Link EHRs with EDC

    Clinical Research News | “Thirty to 40% of clinical trial costs are associated with actually just the manual retyping of [EHR] data [into the clinical trial system], and it leads to reporting delays and a number of other inefficiencies,” Adam Asare, chief data officer at the Quantum Leap Healthcare Collaborative/UCSF, told the Bio-IT World Conference & Expo audience last month. Asare shared a solution to that problem: a collaboration with OpenClinica that won the team a Bio-IT World Innovative Practices Award.

    Jun 16, 2022

  • PCORI Board Approves Strategic Plan, Funding for Maternal Health, Telehealth

    Clinical Research News | The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors has approved the development of new research funding opportunities, providing up to $63 million for studies on reducing maternal health inequities and up to $50 million for research on using telehealth to improve management of multiple chronic conditions.

    Jun 14, 2022

  • A 20-Year Perspective On Breast Cancer Clinical Trials

    Clinical Research News | Wider availability and uptake of mammography screening globally among women under age 60 closely align with a threefold increase in their participation in breast cancer clinical trials over the past two decades. The numbers jumped most dramatically, from 39% to 87%, between the 2005-2009 and 2010-2014 time periods. Those demographics should be prompting sponsor companies to take a fresh look at how they are designing studies in terms of who should and could be included. More can be done to improve clinical trial diversity while being mindful of the duty to protect subjects from harm.

    Jun 14, 2022

  • Side Effects Of Cancer Treatment Could Be Tempered By Intermittent Dosing

    Clinical Research News | The frequency, degree, and speed of onset of immune-related adverse events from the experimental cancer drug AMG319, an inhibitor of phosphoinositide 3-kinase δ (PI3Kδ), came as an unwelcome surprise in a recent clinical trial involving patients in the UK with head and neck cancer. But the study also served to highlight how “absolutely critical” understanding of the immune system is to the development of rational immunotherapy.

    Jun 9, 2022